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by Hershal C. Brewer

My previous article, “Out or In: The Challenge of Calibration Management” (appearing in the February 2005 issue of Quality Digest) addressed the question of whether to use internal or external calibration laboratories. That article also explored the issues involved with managing calibration, including accreditation, the competitive bid process, the use of measurement uncertainty as a risk management tool and the costs involved with calibration. This article will briefly examine the reasons to use an accredited laboratory.

Laboratories
Laboratories that may be used by a manufacturer or other organization come in two basic varieties: calibration and testing. Testing laboratories may be differentiated further into metals, materials, and other categories, and may be internal or external. Calibration laboratories may also be internal or external.

A manufacturer or a similar organization may use a testing laboratory for any of the following reasons:

To perform tests to ensure that a product is ready to be introduced to a market

To ensure that a product is safe and per-forms properly

To meet regulatory requirements such as CE marking

To have products certified by organizations such as Underwriters Laboratories or the Canadian Standards Association

To obtain a particular listing such as the Evaluation Services report from the International Code Council for construction materials and products

 

Such an accreditation is typically used to obtain a competitive advantage or because it is considered “table stakes”--that is, a requirement to sell the goods into the applicable market.

Calibration laboratories are used to ensure that the measurements made by the manufacturer are valid and traceable to national or international standards. The first question for a manufacturer using a laboratory often is: “Do I have a good laboratory?” This article will provide guidance for organizations by discussing accreditation requirements and benefits. For this article, the term “laboratory” will apply equally to testing and calibration because both types receive accreditation under the same standard, ISO/IEC 17025. The terms provided in the previous article are also used as appropriate here.

An accredited laboratory shares many of the same quality management system requirements as an organization registered to ISO 9001, TL 9000 or similar standards. Required processes such as management review, internal audits, customer complaints and contract review are common to both ISO/IEC 17025 and other standards. However, ISO/IEC 17025 has its own unique set of requirements as well. Let’s review some of the specific aspects of these requirements.

Customers are first
The first key to an accredited laboratory, especially an external laboratory, is the confidentiality of the customer information. In other words, if an external laboratory is used that also services competitive organizations, that laboratory has a responsibility to maintain the security of all information. ISO/IEC 17025 has several clauses that describe requirements for protection of customer information--specifically electronic information. These clauses include 4.1.5.c, 4.12.1.3, 4.12.1.4 and 5.4.7.2.b. Accrediting bodies (ABs) examine this requirement in detail. If any gap is found that will allow potential access to customer records by anyone who shouldn’t have that access, it’s seen as a very serious issue. This potential access could be of an external or internal nature. ABs consider any unauthorized access unacceptable.

Management review is also considered a central requirement for accreditation. Section 4.14.1 of ISO/IEC 17025 describes a prescriptive agenda that must be included as part of management review. Other topics that are applicable to the business operations can and should be included. A laboratory can conduct management reviews annually or divide the agenda into smaller groups, with several reviews held during the year. The prescriptive agenda includes both historical and future components.

Two of the requirements include specific review of customer complaints and client feedback. Both are specified independently but may be reviewed together because they are related. However, the AB must be able to distinguish both separately in the management review. Note 3 of section 4.7 strongly suggests that laboratories seek feedback.

Other requirements for management review include internal and external audit results. The reason to specifically review both internal and external audits is self-evident.

Proficiency testing and/or interlaboratory comparison (PT/ILC) results must also be specifically reviewed. As a condition of accreditation, laboratories are required to participate in PT/ILC where it exists. This requirement is one of the potential means of “assuring the quality of test results” as described in section 5.9. ABs that are recognized nationally or internationally under the International Laboratory Accreditation Cooperation (or one of its regions) review this requirement in detail during an assessment. PT/ILC is a benchmarking exercise that illustrates a laboratory’s performance in comparison to other laboratories that perform the same test or calibration.

PT/ILC helps identify strong points and weak points within the laboratory’s technical processes. The obvious implication is that a laboratory with good performance in PT/ILC is a “better” laboratory. That is not necessarily true, as many factors can affect performance in PT/ILC. If an organization is reviewing a laboratory for potential or continued use, the two points that should be examined are the performance of the laboratory in all PT/ILC for the last two years, and what corrective and preventive actions were implemented if the performance wasn’t acceptable. A laboratory’s performance is considered unacceptable if its PT/ILC results are outliers relative to the norm. The instructions for the PT/ILC will often specify what constitutes an outlier.

Internal audits are reviewed by the AB as well as management. An internal audit can be a good tool for monitoring the pulse of an organization. However, an internal audit that is less than one sheet and is completed at 4 p.m. on the Friday just before New Year’s Eve is simply a paper exercise. An internal audit under an accreditation must include both the quality and the technical aspects of the laboratory and must be thorough enough to allow an evaluation of the effectiveness of the audit.

Supporting requirements
An accredited laboratory must comply with a number of supporting requirements. These requirements are intended to ensure the technical proficiency of the laboratory and to protect the interests of the customer.

Subcontracting is one such requirement. A laboratory may subcontract tests or calibration for various reasons, but certain criteria must be met. The customer must be informed in writing by the laboratory prior to the subcontracting of the work. Once the report or certificate is issued by the laboratory to the customer, the subcontractor and the subcontracted work performed must be clearly identified. Also, the laboratory assumes full responsibility for the work of the subcontractor. These requirements are put in place entirely for the protection of the customer to ensure that the work and the protections are consistent. The requirements for subcontracting can be found in section 4.5.

Another requirement is contract review, or understanding the needs of the customer. This requirement is described in section 4.4, and states that:

The needs of the customer and the methods to be used must be defined, documented and understood.

The laboratory must have the capability and resources to meet the requirements.

Methods appropriate to the customer’s needs are selected

 

The contract review must include any work that the laboratory will subcontract. In the event that subcontracting becomes necessary for unforeseen reasons, then the customer must be apprised as soon as possible and all affected parties notified of the amended contract. Records of the reviews and even conversations with the customer must be documented. The requirements in this section are partly for the protection of the customer and partly for the protection of the laboratory.

The accredited laboratory must have a policy to avoid activities that would compromise confidence in its competence (technical proficiency), impartiality, judgment or operational integrity. This provision is also meant to protect both the customer and the laboratory by requiring a high ethical standard for the laboratory personnel.

No laboratory is perfect. Sometimes a laboratory produces a test or calibration that is clearly not acceptable. In such a case, the laboratory is required to have and implement a procedure for the control of nonconforming work. This procedure must specify the following:

Who has the authority to stop work that is suspected of being nonconforming?

How is the nonconforming work investigated?

Who decides on the acceptability of the work?

How is the client notified?

Who decides when the work is to be resumed?

 

Corrective action must be employed if nonconforming work casts any doubt on the laboratory’s adherence to its own policies and procedures.

Technical requirements
An accredited laboratory must have its technical operations assessed. The result of the assessment is visible in a scope of accreditation. A scope is a summary of the tests and/or calibrations that a laboratory is accredited to perform. A laboratory may also perform tests and/or calibrations outside of its scope but that must be clearly identified in the report.

The technical portions of the assessment have both internal and external parts. That is, the internal auditors should audit the technical operations concentrating on such aspects as training and qualification, and on control issues such as tracking equipment and the calibration program. External assessments are third party in nature and are necessary to achieve accreditation. The technical portion may be performed by the AB’s staff if they are qualified, or by a contract assessor. However, if a contract assessor is used, the AB must accept full responsibility for the assessment and any accreditation decisions. The AB isn’t allowed to contract out such decisions.

This technical assessment must be done by someone familiar with the work being performed. For example, a chemist would not assess a fire test, and a microwave calibration technician would not assess a machine shop. The chemist and microwave technician could, however, receive sufficient training and some experience under supervision to become qualified for other assessment fields and disciplines.

Other technical requirements include training and qualification of personnel. The qualification must be specific to the person and task or discipline and include the date of qualification.

Traceability of all measurements, including measurement uncertainty, is a requirement. Test laboratories are not currently required to report uncertainty unless requested by the customer; however, as more customers become familiar with measurement uncertainty as a risk management tool, that may change. Calibration laboratories should be reporting measurement uncertainty for calibrations performed under the scope of accreditation.

Reports and certificates must have specific information. The requirements are documented in section 5.10. The exact format and length of each report or certificate is open, so long as the required information is included.

Summary
The use of an accredited laboratory by an organization is a smart move. The customer is protected because the laboratory has many specific requirements to meet, and its technical proficiency has been verified. An accredited laboratory may cost a bit more, but the question is whether the customer wants to use a laboratory with high standards or one with potentially no standards at all?

About the author
Hershal Brewer is an accreditation assessor for the International Accreditation Service, performing assessments of calibration and testing laboratories to ISO/IEC 17025, and of inspection agencies to ISO/IEC 17020. He is the former corporate lead auditor and corporate metrologist for Newport Corp., and the primary author of the Measurement Uncertainty Primer, available through the International Code Council (ICC). Brewer is also the co-author of the Metrology Handbook, available through the American Society for Quality.